Model Number MI1250 SYNCHRONY 2 PIN |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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Patient Problems
Ossification (1428); Therapeutic Effects, Unexpected (2099)
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Event Date 01/06/2021 |
Event Type
Injury
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Manufacturer Narrative
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The device has not been explanted.If it should be explanted, it is to be returned to the manufacturer for evaluation.When available, a device failure analysis will be submitted as a follow up report.
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Event Description
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The recipient's hearing performance with the device is affected.Imaging confirmed that the electrode array is not completely inserted in the cochlea.Surgery to reinsert array is scheduled on (b)(6) 2021.
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Manufacturer Narrative
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Conclusions: device investigation did not reveal any device defect or damage which is expected to have been present whilst implanted after first surgery.Damages found during device investigation are likely related to the explantation surgery or possibly to the reinsertion attempts done at revision surgery.During investigation the device is working within specification.According to the received information, the device was explanted because it was not providing benefit to the recipient due to a medical reason, namely the active electrode migrated post-operatively out of the cochlea because of ossification and growth of fibrotic tissue, as confirmed by post-operative diagnostic imaging.The recipient was re-implanted with a device from another manufacturer.This is a final report.
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Event Description
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The recipient's hearing performance with the device was affected.At a revision surgery on (b)(6) 2021 it was confirmed that only 2-3- contacts of the electrode were still inside the cochlea and the rest were extra-cochlear.According to the surgeon, the electrode aray had been pushed out by ossification and fibrotic growth.Despite efforts the array could not be inserted any further and therefore it was left in place at the same insertion depth.Afterwards, the user could detect auditory sensation on 2 active electrodes.The user was re-implanted with a competitor's device on (b)(6) 2021.At re-implantation it was confirmed that ossification at the basal turn pushed the electrode out of the cochlea.
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Search Alerts/Recalls
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